AsiaNet 89363

TEL AVIV, Israel, May 5, 2021, /PRNewswire=KYODO JBN/--

The U.S. Food and Drug Administration (FDA) has granted Donisi's

[https://donisihealth.com/ ] revolutionary contact-free multiparameter

measurement system de novo clearance, making Donisi

[https://www.linkedin.com/company/donisihealth/ ] the first to bring this

innovative technology to the medical market.

In addition to the de novo clearance, the ingenuity of Donisi's groundbreaking

system was recently recognized via the publication

[https://www.tandfonline.com/doi/full/10.1080/03091902.2021.1905896 ] of their

clinical validation study in the Journal of Medical Engineering & Technology

and winning first place

[https://www.linkedin.com/feed/update/urn:li:activity:6790305826100797440 ] in

the MEDinISRAEL OpenMED Innovation Competition.

"I'm really proud of our team; we developed a medical device that can change

the lives of millions of people. Our novel technology is now recognized and

cleared by FDA which is a great accomplishment," said Donisi CEO, Yair Brosh.

Backed by 26 granted patents, the system applies a combination of proprietary

optics, algorithms, and artificial intelligence to remotely detect and analyze

surface-level micro-vibrations caused by the workings of internal organs such

as heart and lungs.

Clinical results demonstrate Donisi's technology maintains medical grade

accuracy for people with different medical and physical conditions (physique,

skin tone, etc.), without needing to remove clothing or connect the patient to

wires or patches.

The company continues to develop its system, building ground-breaking solutions

to measure and detect additional cardiopulmonary parameters, such as pulmonary

congestion, in collaboration with the Cardiovascular Research Center at the Tel

Aviv Sourasky Medical Center. Donisi has already undergone the FDA

Presubmission process for the identification of atrial fibrillation (AFib) and

plans for additional submissions.

"Having been with the company since its first year, I am awed and inspired to

be part of the team that is bringing this amazing futuristic technology to

life," said Donisi Chief Medical Officer Dr. Sagi Polani. "This is an exciting

step in our path to fulfilling our mission of changing lives without changing

lifestyles. As we move forward, I can envision how our medical device will

bridge the continuum of care from hospital to home, impacting lives and

health," he continued.

"Chartered Group's investment in Donisi Health indicates our belief in its

development of the innovative optical sensing system that would contribute to

resolve various challenges in the healthcare market including the silver

tsunami and shift from hospital care to home care," said Eyal Agmoni, Chairman

of Chartered Group Technology Division, Donisi's lead investor, and Managing

General Partner of Japan Israel High Tech Ventures 2. "The medical market's

response to this development has been extremely enthusiastic and we are excited

with the progress made by such a dedicated team of experts."

For more information or to request an interview, please reach out to Donisi

Health

[mailto:info@donisihealth.com?subject=Donisi%27s%2520FDA%2520Clearance%2520-%252

0PR ].  

Photo - https://mma.prnewswire.com/media/1483623/Donisi_Health_Measurement.jpg

SOURCE: ContinUse Biometrics, dba Donisi Health, Donis